Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 09 Sep 2021
Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates
9 September 2021 - Senate lawmakers are actively considering pegging the prices Medicare pays for drugs to those drug makers ...
Posted by Michael Wonder on 09 Sep 2021
Biden Administration unveils plan to cut prescription drug prices
9 September 2021 - The Department of Health and Human Services plan supports legislation to empower the government to negotiate Medicare ...
Posted by Michael Wonder on 09 Sep 2021
Insurance benefits for Pfizer’s heart drug Vyndamax uncertain
9 September 2021 - Pfizer’s Vyndamax (tafamidis), a treatment for transthyretin amyloid cardiomyopathy, got in the European Society of Cardiology’s ...
Posted by Michael Wonder on 09 Sep 2021
Professor Gillian Leng to retire from NICE
9 September 2021 - Professor Leng has spent more than 20 years working at NICE. ...
Posted by Michael Wonder on 09 Sep 2021
Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations
9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...
Posted by Michael Wonder on 09 Sep 2021
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...
Posted by Michael Wonder on 09 Sep 2021
FDA grants Jardiance breakthrough therapy designation for heart failure with preserved ejection fraction
9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...
Posted by Michael Wonder on 09 Sep 2021
NICE recommends treatment for people with juvenile idiopathic arthritis
9 September 2021 - NICE has today published final draft guidance which recommends tofacitinib (Xeljanz; Pfizer) as an option for treating ...
Posted by Michael Wonder on 09 Sep 2021
Health funds reject claims hospitals hit by prostheses reforms
9 September 2021 - Health insurers say private hospital operators will not be left out of pocket, rejecting claims they ...
Posted by Michael Wonder on 09 Sep 2021
Merck’s Keytruda (pembrolizumab) approved in China in combination with chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic oesophageal or gastro-oesophageal junction carcinoma
7 September 2021 - Keytruda is now approved for eight indications across five different types of cancer in China. ...
Posted by Michael Wonder on 09 Sep 2021
Controversy over using quality adjusted life years in cost effectiveness analyses: a systematic literature review
8 September 2021 - Researchers and policy makers in the US are exploring the implementation of health technology assessment and value ...